MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER 24 G X 0.56 IN.; INTRAVASCULAR CATHETER

Catalog Number 381511

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Cellulitis (1768); Cyst(s) (1800)

Event Date 11/06/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that ¿several babies have developed pustules, cysts, infections and iv tracks after the removal of the¿ bd insyte-n¿ autoguard¿ shielded iv catheter 24 g x 0.56 in.It was also reported that some of the pediatric patients were (b)(6) for (b)(6) and cellulitis.There were no medical interventions reported.

Manufacturer Narrative

The following fields have been updated with corrections: "it was reported one baby was positive for mrsa at the site and also in the blood.".

Event Description

It was reported one baby was positive for mrsa at the site and also in the blood.

Event Description

It was reported that ¿several babies have developed pustules, cysts, infections and iv tracks after the removal of the¿ bd insyte-n¿ autoguard¿ shielded iv catheter 24 g x 0.56 in.It was reported one baby was positive for mrsa at the site and also in the blood.There were no medical interventions reported.

Manufacturer Narrative

Investigation summary: dhr review was performed on lot number: 8134857; the lot number was built on afa line 4 from 16may2018 thru 23may2018.Packaged on packaging line 10 from (b)(6) 2018 thru (b)(6) 2018.Review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the pir.No quality notification were initiated during the build of this lot number.Observations and testing could not be performed because units were not received for investigation of this incident.Conclusion: indeterminate ¿ without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.

• Brand Name: BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER 24 G X 0.56 IN.
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8096121
• MDR Text Key: 128104273
• Report Number: 1710034-2018-00850
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903815112
• UDI-Public: 30382903815112
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 381511
• Device Lot Number: 8134857
• Date Manufacturer Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other